Elecsys FT3 IIIRecalls & reported problems across all models

We found 4 models of Elecsys FT3 III by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 283 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2018 and Sep 28, 2026 — classified as 1 injury, 282 malfunctions.

The most frequently reported specific device problem is “High Test Results” (237 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys FT3 III problems

Elecsys FT3 III models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys FT3 III 09005811190

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  134 reports
• Elecsys FT3 III 07027362190

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  111 reports
• Elecsys FT3 III 09005803190

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  35 reports
• Elecsys FT3 III 6437206160

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  3 reports

Recent Elecsys FT3 III adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917884 ↗
• MalfunctionApr 27, 2026Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE MINDRAY METHOD. 2. PATIENT AGE RANGE: 11 YEARS 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: MALE 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002377 ↗
• MalfunctionApr 27, 2026Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM) AND ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO THE ABBOTT ASSAY. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002175 ↗
• MalfunctionApr 27, 2026High Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002174 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866276 ↗
• MalfunctionOct 23, 2025Non Reproducible Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369488 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 3 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS AND 2 PATIENTS FROM COBAS 8000 CORE UNITS. 2. PATIENT AGE RANGE: ASKU, 19-69. YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 1-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586746 ↗
• MalfunctionJul 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS FT3 III ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT AGE RANGE: ASKU. PATIENT WEIGHT RANGE: ASKU. PATIENT SEX BREAKDOWN: ASKU. PATIENT RACE BREAKDOWN: ASKU. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586707 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III, ELECSYS FT4 IV, AND ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTS MEASURED ON THE E 801 ANALYZER DID NOT COMPARE TO RESULTS MEASURED USING THE ABBOTT METHODS. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE RESULTS MEASURED ON THE E 801 ANALYZER ARE AS FOLLOWS: FT3 = 12.2 PMOL/L (REFERENCE RANGE = 3.1 - 6.8 PMOL/L), FT4 = 59.9 PMOL/L (REFERENCE RANGE = 12 - 22 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = 14.00 IU/L (POSITIVE). THE RESULTS MEASURED USING THE ABBOTT METHOD ARE AS FOLLOWS: FT3 = 4.08 PMOL/L (REFERENCE RANGE = 3.45 - 5.5 PMOL/L), FT4 = 14.08 PMOL/L (REFERENCE RANGE = 11.0 - 17.7 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = <0.7 IU/L (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088283 ↗
• MalfunctionApr 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925117 ↗
• MalfunctionApr 29, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WERE ALLEGATIONS OF DISCREPANT HIGH RESULTS FOR 6 PATIENTS TESTED FOR ELECSYS FT3 III. THE EVENTS INVOLVED 2 COBAS 8000 E 801 MODULES, 2 COBAS 8000 CORE UNITS, A COBAS 6000 E601 MODULE, AND A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: 1 ASKU, 40 - 79 YEARS. 3. PATIENT WEIGHT RANGE: 6 ASKU. 4. PATIENT SEX BREAKDOWN: 2 ASKU, 4 FEMALES. 5. PATIENT RACE BREAKDOWN: 6 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: 6 ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925101 ↗
• MalfunctionFeb 4, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. OF THE DATA PROVIDED, THE RESULTS FOR FT3, T4, T3, ANTI-TG, AND ANTI-TPO WERE DISCREPANT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306974 ↗
• MalfunctionJan 30, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT ON A COBAS 8000 CORE UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273003 ↗
• MalfunctionJan 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: ASKU, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232801 ↗
• MalfunctionJan 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE FT3 G3 ELECSYS E2G RESULTS FOR 1 PATIENT FROM THE COBAS 8000 CORE UNIT, 2 PATIENTS FROM COBAS 8000 - COBAS E 602 MODULES, AND 2 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 37-85 YEARS, 3-ASKU, 3. PATIENT WEIGHT RANGE: 5-ASKU, 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 3-ASKU, 5. PATIENT RACE BREAKDOWN: 5-ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 5-ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232797 ↗

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